Regulatory CONTRACT Role ** Manage CTAs in EU and RoW ** Home Working Available, UK

Reference: Oli10549B

Expiry Date: 20-01-2021

Category Regulatory Affairs

Salary: On Application

Job Type: Contractor

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

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Job Description

Regulatory CONTRACT Role ** Manage CTAs in EU and RoW ** Home Working Available, UK

We have a new Regulatory Affairs Contract role based in the M4 Corridor of Berkshire for our global Pharmaceutical client with the focus on supporting development projects through managing the liaison with CROs for EU and International Clinical trials in Phases 1,2 and 3.

You will have great flexibility on working hours and also working from home and although this is a contract role you will part of a strong and established team that work cohesively and share a number of project responsibilities.

Role:

  • Manage Clinical Trial Applications (CTA’s) in EU and provide operational regulatory support and guidance in cross-functional clinical trial teams (internal and external).
  • Manage clinical trial submissions to agreed project targets, and oversee the work of the assigned Contract Research Organization (CRO).
  • Work flexibly within the EU team to provide broad operational for initial clinical trial applications, Q&A with Authorities/Ethics Committees, study maintenance, amendments, trial closure activities and archiving of trial documents.
  • The ideal candidate also has experience with assisting in the review and preparation of protocol/IB/IMPD and other CTA documents.
  • This is a great role because you are part of a strong EU Regulatory Affairs development team interacting with the Regulatory Managers, Snr Managers, Associate Directors and GRL’s on EU and Global development projects in a varied role that will keep you busy and energised.

It’s essential to have at least 3 years’ experience in regulatory affairs with a good working of knowledge of clinical development activities.

On offer is a good hourly rate, with flexibility for home working in a really friendly and motivated regulatory team!

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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